Needle assembly and components thereof

ABSTRACT

Needle assemblies are generally discussed herein with particular discussions extended to needle assemblies having a tip protector with a plurality of wall surfaces for preventing contact with the needle tip from a side. Aspects of the tip protectors discussed herein include a first protector body having an arm for blocking a needle tip surrounded by a second protector body having a plurality of wall surfaces.

CROSS-REFERENCE TO RELATED APPLICATION

This is a continuation of application Ser. No. 15/269,583, filed Sep.19, 2016, the contents of which are expressly incorporated herein byreference.

FIELD

Needle assemblies are generally discussed herein with particulardiscussions extended to needle assemblies having a tip protectorcomprising enclosed wall surfaces for preventing contact with the needletip from a side.

BACKGROUND

Insertion procedure for an IV catheter assembly contains four basicsteps: (1) the healthcare worker inserts the needle and cathetertogether into the patient's vein; (2) after insertion into the vein withthe needle point, the catheter is forwarded into the vein of the patientby the healthcare worker pushing the catheter with his or her finger;(3) the healthcare worker withdraws the needle by grasping the hub end(opposite the point end) while at the same time applying pressure to thepatient's skin at the insertion site with his or her free hand; and (4)the healthcare worker then tapes the now inserted catheter to thepatient's skin and connects the exposed end of the catheter (thecatheter hub) to the source of the fluid to be administered into thepatient's vein.

The problem is that, immediately after the withdrawal of the needle fromthe patient's vein, the healthcare worker, who is at this time involvedin at least two urgent procedures, must place the exposed needle tip ata nearby location and address the tasks required to accomplish theneedle withdrawal. It is at this juncture that the exposed needle tipcreates a danger of an accidental needle stick, which, under thecircumstances, leaves the healthcare worker vulnerable to thetransmission of various dangerous blood-borne pathogens, including AIDSand hepatitis.

Other needle types similarly expose healthcare workers to risks ofaccidental needle sticks. For example, a doctor administering aninjection, using a straight needle, a Huber needle, an epidural needle,etc., may place the used needle on a tray for subsequent disposal by anurse. For the period between placing the used needle on a tray or awork station to the time it is discarded, the used needle is a potentialsource for disease transmissions for those that work near or around theneedle. Accordingly, all needles should be covered immediately followinguse to ensure greater worker safety. Ideally, the procedure for coveringthe needle tip should be passive, self activating, or at least simple toperform. In addition, the device for covering the needle should bereliable and robust.

SUMMARY

In accordance with aspects of the present invention, a tip protector isprovided that blocks the needle tip from direct contact with a needletip.

More preferably, the tip protector incorporates side walls for providingshielding the needle tip from view and exposure to blood dripping fromthe inside of the needle tip.

In a further aspect of the present invention, a deflector plate isprovided to deflect the needle from inadvertently re-emerging fromwithin the tip protector.

In yet another aspect of the present invention, the deflector plate isused, at least in part, to position the tip protector within a housing.

It is another object of the present invention to incorporate the tipprotector in a safety IV catheter for automatically shielding a needletip upon removal of a needle from a catheter tube by means of aresilient engagement between the tip protector and the catheter hub. Theresilient engagement allowing for a relatively smoother release withouthaving to reduce typical manufacturing tolerances.

Aspects of the present invention may be practiced by providing a tipprotector for blocking a needle tip comprising: a tip protector housingpositioned inside a hub having an interior surface; a needle passingthrough the tip protector and the housing; a first arm extending from adistal wall of the tip protector housing biased against the interiorsurface; a second arm extending from a proximal wall of the tipprotector housing biased against the interior surface; and a third armextending from the proximal wall of the tip protector housing and biasedagainst a side of the needle.

The present invention may also be practiced by providing a tip protectorfor mounting on a needle to shield a needle tip comprising: a firstprotector body comprising a proximal wall and an arm extending distallyof the proximal wall; said arm further comprising: a distal wall at anend of the arm for blocking a needle tip; a non-uniform arm width foraccommodating a needle extending from between the proximal wall and thedistal wall; a second protector body attached to the first protectorbody, the second protector body comprising a distal wall and two sidewalls defining a cavity for accommodating the first protector body; anda deflector plate comprising a projection projecting into the cavity,the projection and the distal wall at the end of the arm are configuredto limit movement of a needle tip from moving distally of the distalwall of the second protector body.

In yet another aspect of the present invention, there is provided a tipprotector for mounting on a needle to shield a needle tip comprising: afirst protector body attached to a second protector body; the firstprotector body comprising a proximal wall and an arm, which comprises adistal end portion of the arm, extending distally of the proximal wall;the second protector body comprising two side walls and two end wallsdefining a cavity for accommodating the first protector body; the twoside walls each comprising a first edge and a second edge; a deflectorplate comprising a projection projecting into the cavity, the deflectorplate is configured to deflect and move relative to both the first edgeand the second edge; and wherein the projection and the distal endportion of the arm are configured to be on different sides of a needleshaft defined by a centerline when the tip protector is mounted on aneedle and the tip protector is in a ready to use position.

In still yet another aspect of the present invention, there is provideda needle assembly comprising: a housing comprising a wall having aninterior wall surface defining a cavity having a tip protector disposedtherein; a needle, which has a shaft having a first side and a secondside defined by a centerline and a needle tip, passing through thehousing and the tip protector; the tip protector comprising a distalwall, two side walls, a proximal wall, a first arm extending from theproximal wall towards the distal wall, a second arm, which is shorterthan the first arm, extending from the proximal wall, and a wallopposite the second arm; and wherein the wall opposite the second armand the second arm are both biased against the interior wall surface ofthe housing.

Other aspects and features of the tip protectors provided herein may bebetter appreciated as the same become better understood with referenceto the specification, claims, and appended drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The appended drawings include:

FIGS. 1A and 1B are semi-schematic views in partial cross-section of aprior art safety IV catheter incorporating a tip protector comprising anupper wall and two side walls;

FIG. 2 is a semi-schematic perspective view of a tip protector providedin accordance with aspects of the present invention comprising a firstprotector body and a second protector body for blocking a needle tip;

FIG. 3 is a top view of the tip protector of FIG. 2;

FIG. 4 is a bottom view of the tip protector of FIG. 2;

FIG. 5 is a semi-schematic cross-sectional side view of the clip of FIG.4 taken along line 5-5;

FIG. 6 is a semi-schematic end view of the clip of FIG. 5 taken alongline 6-6;

FIG. 7 is a semi-schematic front view of the clip of FIG. 5 taken alongline 7-7;

FIG. 8 is a semi-schematic cross-section side view of the firstprotector body of FIG. 2 shown without the second protector body;

FIG. 9 is a semi-schematic cross-sectional end view of an arm of thefirst protector body of FIG. 8 taken along line 9-9;

FIG. 10 is a semi-schematic end view of the first protector body of FIG.8 taken along line 10-10;

FIG. 11 is a semi-schematic cross-sectional side view of a catheterassembly incorporating the tip protector of FIG. 2 shown in a ready touse position;

FIG. 12 is a cross-sectional end view of the catheter assembly of FIG.11 taken along line 12-12;

FIG. 13 is a partial cross-sectional side-view of the catheter assemblyof FIG. 11 shown with the needle hub retracted from the catheter tubeand the tip protector blocking the needle tip, in a used position;

FIG. 14 is a partial cross-sectional side view of the needle hubcompletely removed from the catheter hub with the tip protector of FIG.2 remained on the needle for blocking the needle tip; and

FIG. 15 is a semi-schematic perspective view of an alternative secondprotector body provided in accordance with aspects of the presentinvention.

DETAILED DESCRIPTION

The detailed description set forth below in connection with the appendeddrawings is intended as a description of the presently preferredembodiments of a tip protector for use on a number of needles or needleassemblies provided in accordance with aspects of the present inventionand is not intended to represent the only forms in which the presentinvention may be constructed or utilized. The description sets forth thefeatures and the steps for constructing and using the tip protector ofthe present invention in connection with the illustrated embodiments. Itis to be understood, however, that the same or equivalent functions andstructures may be accomplished by different embodiments also intended tobe encompassed within the spirit and scope of the invention, especiallythose incorporating a combination of features shown in the differentembodiments included herein. As denoted elsewhere herein, like elementnumbers are intended to indicate like or similar elements or features.

FIGS. 1A and 1B illustrate a prior art spring clip needle guard shownand described in U.S. Pat. No. 6,616,630 to Woehr et al., the contentsof which are expressly incorporated herein by reference. Forcross-referencing purposes, FIGS. 1A and 1B shown herein are labeled anddiscussed in the '630 patent as FIGS. 4A and 4B. As therein shown andreproduced above as FIGS. 1A and 1B, the spring clip needle guard 40 aincludes a distal arm 65 terminating at its upper end in a curved lip 66and at its lower end in a U-shaped portion 67 which, in the readyposition illustrated in FIG. 1A, contacts a bump 68 formed in the lowerinner wall of the catheter hub 26.

A transverse segment 69 having a central opening 70 extends proximallyand upwardly and terminates at an upper U-shaped portion 72. Asdisclosed in the '630 patent, the opening is configured to clamp theneedle in a used position, at points d and e, which have been added. Aproximal end wall 74 having an opening 76 extends vertically fromportion 72 and then extends distally in a horizontal lower segment 78,which has an opening 80 through which the lower halves of the distal arm65 and the transverse segment 69 extend in the ready position of theneedle guard. Segment 78, at its distal end, extends upwardly at a frontwall 82 which has a central opening 84 axially aligned with openings 70,76. At its upper end, the distal front wall 82 extends in the proximaldirection in an upper segment 86, which, as shown in FIG. 1A, contactsthe upper inner wall of the catheter hub along substantially its entirelength.

When the catheter is in the ready position, the needle shaft passesthrough openings 70, 76 and 84 and rests on the curved lip 66, whichurges the arm 65 against the bump 68 in the lower wall of the catheterhub. That engagement, along with the resilient engagement of the uppersegment 86 with the upper interior wall of the catheter hub, retains thespring clip 40 a in its ready position within the catheter hub.

When the needle hub 12 and needle 16 are retracted to the right, asviewed in FIG. 1A, by a sufficient amount, the needle tip 18 movesproximal of the lip 66 and eventually passes below the lip 66. When thisoccurs, the downward force on the arm 65 releases thus allowing the arm65 to snap upwards to the retracted position illustrated in FIG. 4B, inwhich the arm 65 and the lip 66 extend over the needle tip 18 to therebyprevent accidental contact with the needle tip. In this condition, theneedle guard 40 a is clamped onto the needle shaft 16 at points d and eof opening 70 and the needle and needle guard clamped thereto can bereadily removed from the catheter hub.

While the prior art tip protector 40 a shown in FIGS. 1A and 1B iswell-designed for its intended purposes, there remains a number ofimprovements to the tip protector 40 a that could be made to make itmore reliable, effective, and easier to manufacture.

With reference now to FIG. 2, a tip protector provided in accordancewith aspects of the present invention is shown, which is generallydesignated 100. In one exemplary embodiment, the tip protector 100comprises a first protector body (See, also FIG. 5) 102 surrounded, atleast in part, by a second protector body 104.

In one embodiment, the second protector body 104 comprises a distal wall106 comprising an opening 108, which is preferably circular inconfiguration. A plurality of walls extend distally of the distal wall106, which include two side walls 110A, 110B and a deflector wall,plate, or arm 112. The second protector body 104 is preferably formedfrom a single stamped or cut-out stainless steel sheet resembling a “T”,which has a circular cut-out 108 at the intersection of the threebranches of the “T” for forming the opening 108 on the distal wall 106.In one exemplary embodiment, the intersection of the T-shape sheet ispressed against a metal form or die, such as carbide, which then formsthe curvilinear perimeter contour 114 around the perimeter of the distalwall 106 while concurrently pushing the two side walls 110A, 110B andthe deflector plate 112 proximally. A bottom perimeter contour can alsoformed by this process.

In one exemplary embodiment, the edges 116 of the two side walls 110A,110B and the deflector plate 112 are formed fitted in the same die usedto form the curvilinear perimeter contour 114 of the distal wall 106.Thus, the intersections 118 between the two side walls 110A, 110B andthe deflector plate 112 are generally curved or smooth rather than atright angles (also shown in FIGS. 6 and 7). As further discussed below,the smooth edges 116 allow the tip protector 100 to contact an interiorsurface of a clip housing or catheter hub over a larger surface area ascompared to corners having a simple right-angle, which would result in asingle point contact. The side walls and deflector plate are preferablyclose enough together to shield the needle tip from view and catch anydrop of blood that may drip from the needle while inside the needle tip.

In one exemplary embodiment, a projection or dimple 120 is incorporatedon the deflector plate 112 for delimiting needle movement in anactivated position, as further discussed below. The width of the dimplesection 120, extending from one side wall 110A to another side wall110B, is slightly less than the width of the deflector plate immediatelyproximally and distally of the dimple section. The dissimilar widthsalong the deflector plate 112 allow the dimple 120 to be formedfollowing formations of the smooth corners 116. However, the tipprotector 100 may incorporate right angle corners at the variousintersections 118 and the deflector plate 112 having a uniform width,which are less preferred, without deviating from the spirit and scope ofthe present invention. An optional opening 122 may be incorporated onthe deflector plate 112 for ease of assembly. For example a pin (notshown) could be inserted through the opening 122 to push the arm 140(FIG. 5) of the first protector body downwards. This could assist inassembling the butt end of a cannula or needle through the protector.Preferably the opening is not necessary as the distal wall 150 of thefirst protector body 102 is formed at an angle thus allowing the buttend of the cannula to simply deflect the distal wall downwards for anautomatic assembly.

FIG. 3 is a top view of the tip protector 100 of FIG. 2. In oneexemplary embodiment, a reduced proximal section 124 is incorporated onthe deflector plate 112, which has a smaller width dimension that thesection immediately distally. A gap 126 is created on each side of thereduced proximal section 124, which is defined in part by each side wall110A, 110B and the reduced proximal portion 124. The two gaps 126,however, can be filled by keeping the same width the entire length ofthe deflector plate 112.

In one exemplary embodiment, a side wall attachment plate 128A, 128B isincorporated at a proximal end of each side wall 110A, 110B. If acenterline or axis is drawn lengthwise of the tip protector 100, the twoside wall attachment plates 128A, 128B are positioned orthogonally ofthe axis and are generally coplanar. However, the two attachment plates128A, 128B can overlap and be non-coplanar without deviating from thespirit and scope of the present invention. As further discussed below,the two attachment plates 128A, 128B are means by which the secondprotector body 104 attaches to the first protector body 102.

FIG. 4 is a bottom view of the tip protector 100 of FIG. 2. The firstprotector body 102 is clearly shown positioned between the two sidewalls 110A, 110B of the second protector body 104. In one exemplaryembodiment, an arm 130 for stabilizing the tip protector 100 within ahousing or hub is incorporated. The arm 130 extends distally from aproximal wall 132 (See also FIG. 5) and includes a bend or apex 133defined by an upstream section 134 positioned at an angle to adownstream section 136 (See also FIG. 5). As further discussed below,the arm 130 is configured to pivot, flex, or cantilevered about a point138 at a proximal end of the tip protector 100, which acts like a hinge.The proximal wall 132 and the two attachment plates 128A, 128B togetherdefine a protector proximal end 129.

An arm 140, of relatively longer length than the arm 130 forstabilizing, for blocking a needle tip also extends from the proximalwall 132. In one exemplary embodiment, the arm 140 comprises an opening142 and two ribs 144. Preferably, the opening 142 has an oblong shapeand the two ribs 144 are formed by a coining process. The arm 140further includes a forearm section 146, a return section 148 (FIG. 5), adistal wall 150 (FIG. 5) for blocking a needle tip, and an end sectionor finger 152 (FIG. 5) for overlapping a portion of the needle in theused position. Together, the forearm section 146, the return section148, the distal wall 150, and the finger 152 are collectively referredto herein as a distal arm blocking section. In one exemplary embodiment,the section of the arm with the opening 142 is wider than the remainingarm sections. This configuration provides room to not only incorporatethe opening 142 but also the two coined ribs 144. Alternatively, a tabor flab may be incorporated on each edge of the arm section and thenbending them to form two ribs. The alternative arm, without the coinedribs, may have a uniform width throughout.

FIG. 5 is a cross-sectional side view of the tip protector of FIG. 4taken along line 5-5. The two arms 130, 140 can be seen extending fromtwo different edges of the proximal wall 132. As shown in FIG. 11, whenthe tip protector 100 is positioned on a needle, the two arms originatefrom opposite side of the needle, viewed from a needle centerline.However, the longer arm 140 extends distally of the proximal wall 132 atan angle and transects the needle axis, with the needle passing throughthe opening 142 on the arm. The short arm 130, however, does not touchor intersect the needle. More preferably, the end edge 154 of the shortarm 130 is spaced apart from the needle, both in a ready to use positionand a used position.

As further discussed below, when the tip protector 100 is in a ready touse position, the long arm 140 is biased radially outwardly towards theshort arm 130 and the finger 152 in contact with a side of the needle.To that end, the long arm 140 is flexed, at least in part, about a point156 at the proximal wall 132 when in abutting contact with a side of theneedle.

Referring again to FIG. 3 in combination with FIG. 5, the deflectorplate 112 is cantilevered from the perimeter contour 114 of the distalwall 106 of the second protector body 104. This allows the wholedeflector plate 112, and more specifically the reduced proximal portion124, to deflect like a springboard. In one exemplary embodiment, thedimension between the apex 133 of the short arm 130 and the roundededges 116 of the deflector plate 112 should be larger than the internalcurvature of a housing the tip protector is to be placed into so thatboth the deflector plate 112 and the short arm 130 are biased inwardlyby the wall surface of the housing. Said differently, when the tipprotector 100 is mounted inside a housing, such as the catheter hubshown in FIG. 11, the tip protector is squeezed at the two rounded edgeson the deflector plate 112 and the short arm 130. This squeezing actionallows the tip protector to be removeably secured to the housing or hub.

FIG. 6 is an end view of the tip protector of FIG. 5 taken along line6-6. The two side attachment plates 128A, 128B are shown in contact withthe proximally facing surface of the proximal wall 132. In one exemplaryembodiment, the two attachment plates 128A, 128B are welded, usingultrasound, high frequency welding, or laser, to the proximal wall 132.An opening 158 is incorporated on the proximal wall 132 of the firstprotector body 102 for receiving a needle (not shown). The twoattachment walls 128A, 128B both incorporate cut-outs 160 resembling twosemi-circles that together have a larger diameter than the opening 158on the proximal wall 132. Alternatively, the two attachment walls 128A,128B can overlap one another and each incorporating a separate openinghaving a larger diameter than the diameter on the opening 158 of theproximal wall.

FIG. 7 is a front view of the tip protector 100 of FIG. 5 taken alongline 7-7. As clearly shown, the second protector body 104 incorporates aplurality of walled structures, namely the two side walls 110A, 110B andthe deflector plate 112, a front wall 106, and two attachment walls128A, 128B (not shown) to form an enclosure comprising a cavity 155 anda central access opening 162 (See also FIG. 5). With reference to FIGS.5 and 6 in addition to FIG. 7, the short arm 130 projects out throughthe central access opening 162 to provide a contact point between thetip protector and a housing, such as a catheter hub. The long arm 140(FIG. 5) similarly projects out through the central access opening 162when in a ready-to-use position but moves into the cavity 155 when in aused position, as further discussed below.

FIG. 8 is a cross-sectional side view of the first protector body 102 ofFIG. 1, shown without the second protector body 104. In one exemplaryembodiment, the first protector body 102 is formed from an singleintegral stainless steel sheet. The opening 142 should be stamped andthe two ribs 144 coined before the first protector body 102 is formed tothe shape shown in FIG. 8.

FIG. 9 is a cross-sectional end view of the first protector body 102 ofFIG. 8 taken along line 9-9. Part of the two ribs 144, the opening 142between the two ribs, and the proximal wall 132 are shown.

FIG. 10 is an end view of the first body section 102 of FIG. 8 takenalone line 10-10. Part of the oblong opening 142 and the distal wall 150can be seen through the opening 158 on the proximal wall 132. In oneexemplary embodiment, four cut-outs 164 are formed at each corner of theproximal wall 132. The cut-outs 164 are configured to reduce the amountof spring force the two arms 130 and 140 generate. The amount of cut outcan be varied to obtain a desired spring force.

With reference again to FIG. 5, the tip protector disclosed herein maybe viewed as a device having a housing with three moveable arms 112,130, and 140. The tip protector may also be viewed as having a housingwith a deflector plate or arm with a tip protector disposed thereinhaving an arm for blocking a needle tip and an arm, together with thedeflector plate, for resiliently securing the tip protector to a hub orclip housing.

FIG. 11 is a semi-schematic cross-sectional side view of a catheterassembly 166 incorporating the tip protector 100 of FIGS. 2-10. Broadlyspeaking, the catheter assembly 168 comprises a needle hub comprising aneedle 170 attached thereto. The needle 170 comprises a sharpened needletip 172, a non-uniform needle section 175 (FIG. 13), and projectsthrough the tip protector 100, the catheter hub 174, and the cathetertube 176. The non-uniform needle section 175 may be a crimp, a materialbuild-up, a bend, or combinations thereof. In a preferred embodiment,the needle hub 168 incorporates a nose section 178 that projects intothe interior wall surface 180 of the catheter hub 174. The nose section178 is configured to push the protector proximal end 129 of the tipprotector 100 to a desired depth or length inside the cavity 182 definedby the wall surface 180 of the catheter hub 174 in the ready to useposition (FIG. 11).

In one exemplary embodiment, the cavity 182 includes a recessed section184, which may extend the entire internal circumference of the cavityalong a band or width or a partial circumference, as shown. The recessedsection 184 provides added space for the distal end of the first bodysection 102 so as to reduce the amount of compression or biasing forceon the finger section 152 and the return section 148. This in turn,reduces the drag between the finger section 152 and the side of theneedle 170 during relative movement between the needle and the tipprotector 100. Obviously, the needle assembly 166 may be practicedwithout the recessed section 184, but not as preferred.

As shown, the recessed section 184 comprises a proximal tapered section186 and a distal tapered section. With reference to FIG. 5 in additionto FIG. 11, the forearm section 146, the return section 148, and thedistal wall 150 of the first body section 102 are all positioneddistally of and spaced apart from the proximal tapered section 186. Thespace apart configuration is incorporated as physical contact betweenthe proximal tapered section 186 and the distal arm blocking section isnot required to maintain a fixed relationship between the catheter hub174 and the tip protector 100 during movement of the needle hub 168relative to the catheter hub. However, contact between the two may beincorporated without deviating from the spirit and scope of the presentinvention.

Referring now to FIG. 12, which is a cross-sectional end view of thecatheter assembly of FIG. 11 taken along line 12-12, the tip protector100 is shown contacting the interior wall surface 180 of the catheterhub 174 at the two curbed edges 116 on the deflector plate 112 and twoedges of the short arm 130, in the general area of the apex 133. Thefour contact points are shown in FIG. 12 with four contact arrows. Thus,in one exemplary embodiment, an arm 130 is cantilevered from a proximalend of the first protector body 102 and another arm 112 is cantileveredfrom a distal end of the second protector body 104 to retain the tipprotector 100 within a catheter hub. Said differently, a tip protectoris herein provided having an arm cantilevered from a proximal wall of aprotector housing and a second arm cantilevered from a distal wall ofthe same protector housing. In an alternative embodiment, the cantileverarm 112 is eliminated and the two side walls 110A, 110B along with theshort arm 130 are configured to removeably secure the alternative tipprotector to a housing, such as a catheter hub or a clip housing.

FIG. 13 is a partial cross-sectional side view of the catheter assembly166 of FIG. 11, shown in a used position, with the needle 170 retractedto the right of FIG. 11. The tip protector 100, hence the needle 170, ismoved to the used position shown in FIG. 13 by holding the catheter hub174 in one hand while withdrawing the needle hub 168 to the right ofFIG. 11 (or vice-versa, i.e., holding the needle hub 168 while movingthe catheter hub 174 to the left of FIG. 11). As the needle tip 172moves proximally of the finger section 152, the biasing force acting onthe arm 140 is removed thus allowing the arm to recoil to its lessflexed state, which is shown in FIG. 13. As the needle hub 168 continuesto move to the right, the non-uniform section 175 on the needle 170,which has a larger cross-sectional dimension than the opening 158 on theproximal wall 132 of the first protector body 102, contacts the opening158 and pulls the proximal wall, via the engagement with the perimeterof the opening 158, to the right. If the pulling force on the proximalwall 132 is greater than the friction force between the cantilever arm112, the short arm 130, and the interior surface 180 of the catheterhub, the friction is overcome and the tip protector 100 disengages fromthe catheter hub.

FIG. 14 shows the tip protector 100 removed from the catheter hub 174and the distal wall 150 blocking the needle tip. As the tip protectorincorporates two side walls 110A, 110B, and a deflector plate 112, thetip protector covers about three quarters of the circumference of theneedle 170 proximate the needle tip. The remaining section of the needle170 proximate the needle tip 172 is also partly covered by the short arm130 and the distal blocking section of the first protector body 102. Theneedle tip is shielded from view or contact. Blood, which may drip fromthe needle tip, is configured to be caught by one of the walls.

As shown in FIG. 14, if a force is exerted at the distal end of the tipprotector near point 189, the needle 170 could pivot away from theshielding provided by the finger section 152 and manipulated so that itre-emerges out the opening 108 of the distal wall 106 of the secondprotector body 104. Accordingly, in one exemplary embodiment, the dimpleor projection 120 on the deflector plate 112 is configured to inhibit ordelimit movement of the needle in the event of a direct or incidentalforce on the tip protector at or near point 189. The projection 120 isconfigured to prevent movement of the needle tip 172 radially of thefinger section 152.

FIG. 15 is a semi-schematic perspective view of a second protector body188 provided in accordance with aspects of the present invention. Thealternative second protector body 188 may cooperate with the firstprotector body shown in FIGS. 8-10 to form an alternative tip protector.In one exemplary embodiment, the alternative second protector body 188incorporates a deflector plate 190 comprising a generally curvilinearexternal surface, a tab 192 formed by making a cut-out 194 on thedeflector plate and including two relief points 196. The tab 192, likethe projection or dimple 120 on the prior second protector body, isconfigured to prevent a needle from pivoting out from the tip protectorinternal space. In one exemplary embodiment, the deflector plate 190 isintegrally formed to the side walls 110A and 110B. This can be done, forexample, using a deep draw forming process. Still alternatively, the twoside walls 110A, 110B and the deflector plate 190 may have a notch ofcut-out between them.

In one exemplary embodiment, a least a portion of the curvilinearexternal surface of the deflector plate 190 is configured to contact theinterior surface of a catheter hub when the same is placed therein aspart of a catheter assembly. Alternatively, the deflector plate 190incorporates a flat surface such that only the two side edges 198 withthe two side walls 110A, 110B contact the interior surface of thecatheter hub or clip housing.

Although limited embodiments of the tip protector and needle devicesincorporating the tip protector have been specifically described andillustrated herein, many modifications and variations will be apparentto those skilled in the art. For example, the tip protector describedherein may be used in combination with a sleeve on a needle having abend such as that shown in U.S. Pat. No. 6,585,704 to Luther et al.Alternatively, the tip protector described herein may be used with anouter housing on a needle for use with a syringe, such as that shown inU.S. Pat. No. 6,595,955 to Fergusson et al. Still alternatively, the tipprotector described herein may be used with a grip part for sliding thetip protector along a needle, such as that shown in Ser. No. 10/856,315,entitled PROTECTIVE DEVICE FOR AN INJECTION NEEDLE. The foregoingpatents and application are expressly incorporated herein by referenceas if set forth in full. Accordingly, it is to be understood that thetip protector and its components constructed according to principles ofthis invention may be embodied other than as specifically describedherein. The invention is also defined in the following claims.

What is claimed is:
 1. A catheter assembly comprising: a catheter hubcomprising a wall having an interior wall surface defining an interiorcavity; a catheter tube attached to and extending distally of thecatheter hub, said catheter tube comprising a distal opening; a needle,which has a lengthwise axis, a sharpened needle tip, and a crimp, amaterial build up, a bend or combinations thereof, passing through thecatheter hub and the catheter tube with the sharpened needle tipextending distally of the distal opening of the catheter tube in a readyto use position; a tip protector assembly removably held in the interiorof the catheter hub, said tip protector assembly comprising a firstprotector body located inside an interior of a second protector body;wherein the first protector body comprises a proximal wall with aperimeter defining an opening having the needle passing therethrough, adistal wall that is movable distal of the needle tip in a protectiveposition to block the needle tip, a first arm having a free endextending distally of the proximal wall from a first side of the needleand extending towards the sharpened needle tip, a second arm having afree end extending distally of the proximal wall from a second side ofthe needle towards the sharpened needle tip, the free end of the firstarm and the free end of the second arm are spaced apart from oneanother, and the second arm comprising a distal end, a proximal end, anda length between the distal end and the proximal end; wherein the crimp,the material build up, the bend or the combinations thereof on theneedle is configured to engage the perimeter defining the opening on theproximal wall of the first protector body to limit the tip protectorassembly from displacing distally off of the needle in a protectiveposition; wherein the second protector body comprises a distal end, aproximal end, and an opening between the distal end and the proximal endof the second protector body; and wherein the second arm comprises acurved arm section located between the distal end and the proximal endof the second arm that extends radially outwardly relative to the needleand externally of the second protector body at the opening of the secondprotector body in the ready to use position.
 2. The catheter assembly ofclaim 1, further comprising a finger located at an end of the distalwall of the first protector body.
 3. The catheter assembly of claim 2,wherein the finger points in a proximal direction.
 4. The catheterassembly of claim 1, wherein the first arm extends further distally thanthe second arm.
 5. The catheter assembly of claim 1, wherein the distalwall is attached to the first arm of the first protector body.
 6. Thecatheter assembly of claim 3, wherein the distal end of the secondprotector comprises a distal wall having an opening having the needlepassing therethrough in the ready to use position.
 7. The catheterassembly of claim 6, wherein the crimp or the material build up islocated inside the interior of the second protector body.
 8. Thecatheter assembly of claim 1, wherein the tip protector assembly iscompletely located inside the catheter hub in the ready to use position.9. A catheter assembly comprising: a catheter hub comprising a wallhaving an interior wall surface defining an interior cavity; a cathetertube attached to and extending distally of the catheter hub, saidcatheter tube comprising a distal opening; a needle hub with a needle,which has a lengthwise axis, a sharpened needle tip, and a crimp or amaterial build up, passing through the catheter hub and the cathetertube with the sharpened needle tip extending distally of the distalopening of the catheter tube in a ready to use position; a tip protectorassembly removably held in the interior of the catheter hub, said tipprotector assembly comprising a first protector body located inside aninterior of a second protector body; wherein the second protector bodycomprises a distal end with a distal wall having a first opening, aproximal end, and a second opening between the distal end and theproximal end of the second protector body, wherein the needle passesthrough the first opening in the ready to use position; wherein thefirst protector body comprises a proximal wall having a perimeterdefining an opening having the needle passing therethrough, a distalwall that is movable distal of the needle tip in a protective positionto block the needle tip, a first arm, which comprises two spaced apartside edges, extending distally of the proximal wall from a first side ofthe needle and extending towards the sharpened needle tip, a second arm,which comprises two spaced apart side edges, extending distally of theproximal wall from a second side of the needle towards the sharpenedneedle tip, and wherein the second arm comprises a distal end, aproximal end, and a curved arm section between the distal end and theproximal end; wherein the curved arm section of the second arm extendsradially outwardly relatively to the needle and externally of the secondprotector body at the second opening of the second protector body in theready to use position; and wherein the crimp or the material build up isconfigured to engage the perimeter defining the opening on the proximalwall of the first protector body to limit the tip protector assemblyfrom displacing distally off of the needle in a protective position. 10.The catheter assembly of claim 9, further comprising a finger located atan end of the distal wall of the first protector body.
 11. The catheterassembly of claim 10, wherein the finger points in a proximal direction.12. The catheter assembly of claim 9, wherein the first arm extendsfurther distally than the second arm.
 13. The catheter assembly of claim9, wherein the distal wall is attached to the first arm of the firstprotector body.
 14. The catheter assembly of claim 11, wherein the crimpor the material build up is located inside the interior of the secondprotector body.
 15. The catheter assembly of claim 9, wherein the tipprotector assembly is completely located inside the catheter hub in theready to use position.
 16. A method of manufacturing a catheter assemblycomprising: providing a catheter hub comprising a wall having aninterior wall surface defining an interior cavity with a catheter tubeattached to a distal end of the catheter hub, said catheter tubecomprising a distal opening; providing a needle hub with a needle, whichhas a lengthwise axis, a sharpened needle tip, and a crimp or a materialbuild up, passing through the catheter hub and the catheter tube withthe sharpened needle tip extending distally of the distal opening of thecatheter tube in a ready to use position; positioning a tip protectorassembly in the interior of the catheter hub, said tip protectorassembly comprising a first protector body located inside an interior ofa second protector body; wherein the second protector body comprises adistal end with a distal wall having a first opening having the needlepassing therethrough in the ready to use position, a proximal end, and asecond opening between the distal end and the proximal end of the secondprotector body; wherein the first protector body comprises a proximalwall having a perimeter defining an opening having the needle passingtherethrough, a distal wall that is movable distal of the needle tip ina protective position to block the needle tip, a first arm, whichcomprises two spaced apart side edges, extending distally of theproximal wall from a first side of the needle and extending towards thesharpened needle tip, a second arm, which comprises two spaced apartside edges, extending distally of the proximal wall from a second sideof the needle towards the sharpened needle tip, and wherein the secondarm comprising a distal end, a proximal end, and a curved arm sectionbetween the distal end and the proximal end; wherein the curved armsection of the second arm extends radially outwardly relatively to theneedle and externally of the second protector body at the second openingof the second protector body in the ready to use position; and whereinthe crimp or the material build up is configured to engage the perimeterdefining the opening on the proximal wall of the first protector body tolimit the tip protector assembly from displacing distally off of theneedle in a protective position.
 17. The method of claim 16, wherein thefirst protector body further comprises a finger located at an end of thedistal wall.
 18. The method of claim 17, wherein the finger points in aproximal direction.
 19. The method of claim 16, wherein the first armextends further distally than the second arm.
 20. The method of claim16, wherein the distal wall is attached to the first arm of the firstprotector body.
 21. The method of claim 18, wherein the crimp or thematerial build up is located inside the interior of the second protectorbody.